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Cognitive Rehabilitation in Patients With Depression

NCT ID: NCT03338413

Last Updated: 2017-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-31

Study Completion Date

2020-06-30

Brief Summary

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Depression is a highly prevalent and debilitating mental disorder, ranked one of the leading causes of disability worldwide. Several studies have identified neuropsychological deficits in populations of depressed patients affecting domains including attention, memory and executive functioning. These deficits often persist even in patients whose depressive symptoms have remitted. Cognitive impairment in depression represent a core feature of depression, and a valuable target for intervention. Identification of methods that would lead to amelioration would be of great clinical interest, and cognitive rehabilitation (CR) could be a potential way of achieving this. To date few studies on cognitive rehabilitation in depression has been conducted, but the preliminary results are promising. Still the demonstration of long-term effects and evidence relating to improved daily life executive functioning (i.e., generalization) is lacking. In the present study different group-based cognitive rehabilitation interventions will be compared. The aim of the study is to investigate if a group-based "brain training" intervention can improve executive function in patients with active and remitted depression. Efficacy will be assessed immediately after intervention, but also six months after the intervention.

Detailed Description

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Conditions

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Depression

Keywords

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Rehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Goal Management Training

Group Type EXPERIMENTAL

Goal Management Training

Intervention Type BEHAVIORAL

9 GMT modules will be administered in 9X2 hour sessions (ten groups). Manualized intervention; metacognitive strategies for improving attention and problem solving.

Computerized Cognitive Training

Group Type EXPERIMENTAL

Computerized Cognitive Training

Intervention Type BEHAVIORAL

9 modules will be administered in 9x1 hour session (ten groups). Computerized Cognitive Training using commercially available web-based platforms based on neuroplasticity, developed to target skills such as attention, memory, speed of processing and executive functioning. Homework assignment between sessions.

Interventions

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Goal Management Training

9 GMT modules will be administered in 9X2 hour sessions (ten groups). Manualized intervention; metacognitive strategies for improving attention and problem solving.

Intervention Type BEHAVIORAL

Computerized Cognitive Training

9 modules will be administered in 9x1 hour session (ten groups). Computerized Cognitive Training using commercially available web-based platforms based on neuroplasticity, developed to target skills such as attention, memory, speed of processing and executive functioning. Homework assignment between sessions.

Intervention Type BEHAVIORAL

Other Intervention Names

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Active control condition

Eligibility Criteria

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Inclusion Criteria

* Completed treatment for mild or moderate MDD
* Evidence of executive dysfunction in everyday life determined by (a) a structured interview or (b) a self-report Behavior Rating Inventory of Executive Function (BRIEF) T-score \< 55.

Exclusion Criteria

* Cognitive, sensory, physical, or language impairment affecting the capacity to complete the training program.
* Premorbid neurological disease or insult and/or comorbid neurological disorder.
* Reported ongoing alcohol or substance abuse.
* Psychotic disorders.
* Actively suicidal.
* Personality disorder sever enough to interfere with the protocol.
* Not fluent in Norwegian language.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Oslo

OTHER

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role collaborator

Lovisenberg Diakonale Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andreas Joner

Role: STUDY_DIRECTOR

Lovisenberg Diaconal Hospital

Locations

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Lovisenberg Diaconal Hospital

Oslo, , Norway

Site Status

Countries

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Norway

Central Contacts

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Jan Stubberud, ph.d

Role: CONTACT

Phone: 95104217

Email: [email protected]

Bjørn Hagen, cand.psychol

Role: CONTACT

Phone: 91301061

Email: [email protected]

Other Identifiers

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2017/666

Identifier Type: -

Identifier Source: org_study_id